Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because bacterial endotoxin testing results were out of specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen indicator (bacterial endotoxin) in a medical device where no illnesses or injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Atrium Medical Corporation is recalling 256 units of Getinge PVC Thoracic Catheters, Firm PVC Straight. The affected products are distributed nationwide in the United States. The specific model numbers involved are 15028 (28FR) and 15036 (36FR).
The recall was initiated due to an Out of Specification (OOS) result related to bacterial endotoxin testing in a single lot of catheters. The affected lot numbers are ME244891 for the 28FR model and ME244850 for the 36FR model.
Healthcare facilities and distributors should stop using these specific lots of catheters. Consumers and medical professionals should check their inventory for the model numbers and lot numbers listed above and contact Atrium Medical Corporation for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 256
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 1. Model Number(Size): 15028(28FR)
- UDI-DI: 00650862150285
- Lot Number: ME244891
- 3. Model Number(Size): 15036(36FR)
- UDI-DI: 00650862150360
- Lot Number: ME244850
Distribution
Distributed nationwide across the United States.
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